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Update Forms/FRM-LAB-001-eeg-equipment-loss-and-quality-control-record-form.md

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Ernie Pedapati
2025-12-29 09:45:49 -05:00
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Forms/FRM-LAB-001-eeg-equipment-loss-and-quality-control-record-form.md
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@@ -5,111 +5,82 @@ date: 2025-12-29
version: "1.0" version: "1.0"
status: "Draft" status: "Draft"
--- ---
## 1. Purpose ## 1. Purpose
*This form is used to document, investigate, and quality control incidents involving loss, damage, or unaccounted EEG nets. The record supports traceability, corrective actions, and compliance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485.* *This form is used to document, investigate, and quality control incidents involving loss, damage, or unaccounted EEG nets. The record supports traceability, corrective actions, and compliance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485.*
## 2. Scope ## 2. Scope
- Applies to all EEG nets owned, leased, or managed by the organization - Applies to all EEG nets owned, leased, or managed by the organization
- Covers loss, misplacement, damage, or failure to return EEG nets after use - Covers loss, misplacement, damage, or failure to return EEG nets after use
- Used by clinical, research, and technical staff handling EEG equipment - Used by clinical, research, and technical staff handling EEG equipment
## 3. Definitions ## 3. Definitions
- **EEG Net**: Reusable or disposable electrode net used for EEG data acquisition - **EEG Net**: Reusable or disposable electrode net used for EEG data acquisition
- **Loss Incident**: Any situation where an EEG net cannot be located, accounted for, or returned as expected - **Loss Incident**: Any situation where an EEG net cannot be located, accounted for, or returned as expected
- **Quality Control (QC)**: Activities ensuring EEG nets are tracked, maintained, and handled according to procedures - **Quality Control (QC)**: Activities ensuring EEG nets are tracked, maintained, and handled according to procedures
## 4. Equipment Identification ## 4. Equipment Identification
*Record identifying information for the affected EEG net(s).* *Record identifying information for the affected EEG net(s).*
| Field | Details | FieldDetailsEEG Net Type/Model""Serial Number / Asset ID""Size""Manufacturer""Quantity Affected""Condition at Last Use""
|------|--------|
| EEG Net Type/Model | "" |
| Serial Number / Asset ID | "" |
| Size | "" |
| Manufacturer | "" |
| Quantity Affected | "" |
| Condition at Last Use | "" |
## 5. Incident Details ## 5. Incident Details
*Describe the circumstances under which the EEG net(s) were lost or discovered missing.* *Describe the circumstances under which the EEG net(s) were lost or discovered missing.*
| Field | Details | FieldDetailsDate of Incident""Time of Incident""Location (Lab/Room/Site)""Study or Session ID""Responsible User""Last Known User""Date Loss Discovered""
|------|--------|
| Date of Incident | "" |
| Time of Incident | "" |
| Location (Lab/Room/Site) | "" |
| Study or Session ID | "" |
| Responsible User | "" |
| Last Known User | "" |
| Date Loss Discovered | "" |
## 6. Description of Loss ## 6. Description of Loss
*Provide a clear and factual description of what occurred.* *Provide a clear and factual description of what occurred.*
| Description | Description""
|------------|
| "" |
## 7. Immediate Actions Taken ## 7. Immediate Actions Taken
*Document actions taken upon discovery of the loss.* *Document actions taken upon discovery of the loss.*
| Action | Responsible Person | Date | ActionResponsible PersonDate""""""""""""
|------|-------------------|------|
| "" | "" | "" |
| "" | "" | "" |
## 8. Quality Control Review ## 8. Quality Control Review
*Assess compliance with equipment handling and tracking procedures.* *Assess compliance with equipment handling and tracking procedures.*
| QC Item | Yes | No | N/A | Comments | QC ItemYesNoN/ACommentsEquipment sign-out procedure followed""""""""Net labeled with asset ID""""""""Storage procedure followed""""""""Inventory log updated""""""""
|-------|-----|----|-----|----------|
| Equipment sign-out procedure followed | "" | "" | "" | "" |
| Net labeled with asset ID | "" | "" | "" | "" |
| Storage procedure followed | "" | "" | "" | "" |
| Inventory log updated | "" | "" | "" | "" |
## 9. Root Cause Assessment ## 9. Root Cause Assessment
*Identify the most likely cause(s) of the loss.* *Identify the most likely cause(s) of the loss.*
| Potential Cause | Selected (Yes/No) | Comments | Potential CauseSelected (Yes/No)CommentsHuman error""""Inadequate tracking process""""Training deficiency""""Process noncompliance""""Other""""
|----------------|------------------|----------|
| Human error | "" | "" |
| Inadequate tracking process | "" | "" |
| Training deficiency | "" | "" |
| Process noncompliance | "" | "" |
| Other | "" | "" |
## 10. Corrective and Preventive Actions (CAPA) ## 10. Corrective and Preventive Actions (CAPA)
*Define actions to prevent recurrence.* *Define actions to prevent recurrence.*
| Action Description | Action Type (Corrective/Preventive) | Responsible Person | Target Completion Date | Action DescriptionAction Type (Corrective/Preventive)Responsible PersonTarget Completion Date""""""""""""""""
|-------------------|------------------------------------|-------------------|-----------------------|
| "" | "" | "" | "" |
| "" | "" | "" | "" |
## 11. Effectiveness Check ## 11. Effectiveness Check
*Evaluate whether implemented actions were effective.* *Evaluate whether implemented actions were effective.*
| Review Date | Method of Verification | Effective (Yes/No) | Comments | Review DateMethod of VerificationEffective (Yes/No)Comments""""""""
|------------|-----------------------|--------------------|----------|
| "" | "" | "" | "" |
## 12. Record Retention and Compliance ## 12. Record Retention and Compliance
- This record is maintained in accordance with document control procedures - This record is maintained in accordance with document control procedures
- Electronic records and signatures comply with FDA 21 CFR Part 11 - Electronic records and signatures comply with FDA 21 CFR Part 11
- Retention period: "" years - Retention period: "" years
## 13. Approval Signatures ## 13. Approval Signatures
*Signatures confirm review, accuracy, and approval of this record.* *Signatures confirm review, accuracy, and approval of this record.*
| Role | Name | Signature | Date | RoleNameSignatureDatePrepared By""""""Reviewed By""""""Approved By""""""
|-----|------|----------|------|
| Prepared By | "" | "" | "" |
| Reviewed By | "" | "" | "" |
| Approved By | "" | "" | "" |
## 14. Version Control ## 14. Version Control
| Version | Date | Description of Change | Author |
|--------|------|----------------------|--------| VersionDateDescription of ChangeAuthor1.02025-12-29Initial draft""
| 1.0 | 2025-12-29 | Initial draft | "" |